ArthroVims BR

Trade name

ArthroVims BR

18904210320479

B-18904210320479

Reference / catalog number

VIMS-10160

GS1

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

ArthroVIMS BR Anchor Ligament Anchor, Bioabsorbable Knotless, Dia. 4.75mm

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P09120102ANCHORS, TENDON AND LIGAMENT SYNTHESIS

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  1. Foreign body sensitivity or Known hypersensitivity to the implant material. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implantation. 2. Insufficient quantity or quality of bone or soft tissue. Pathological conditions of bone & soft tissue, such as cystic changes, tumor or severe osteopenia, which would compromise secure implant fixation. 3. Patient conditions including Blood supply limitation and previous infections which may tend to retard healing. 4. Patients with cognitive impairment or neurologic conditions who are unwilling or incapable of following postoperative care instructions. 5. Acute or chronic local or systemic infection. 6. Conditions which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period. 7. The use of this device may not be suitable for patients with insufficient or immature bone. The physician should carefully assess bone quality before performing orthopedic surgery on patients who are skeletally immature. The use of this medical device and the placement of hardware or implants must not bridge, disturb, or disrupt the growth plate. 8. Do not use for surgeries other than those indicated. 9. Comminuted bone surface is likely to compromise secure implant fixation. 10. Severe muscular, nervous,and/or vascular disorders that could endanger the limb 11. Any concomitant illness and/or dependence that could risk implanting function. 12. Excessive body activities that could cause overloading of the implant. 13. Proven infection or the risk of infection. 14. The medical device is not designed or must never be used to attach artificial ligaments.